Nose and Sinus Cancer
EA3163
Chemotherapy before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients with Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
STATUS: Closed to Accrual
This phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Chemotherapy drugs, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.
- Patients must be >= 18 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have a general physical condition compatible with the proposed chemotherapy and surgery
- Patients must have stage T3 or T4a, histologically-confirmed NPNSCC requiring orbital or skull base resection: (Some patients with T4b disease deemed resectable by the treating surgeon can be included provided they fulfill all other eligibility criteria without involvement of the cavernous sinus
- Patients with T4b who have the following characteristics leading to a T4b definition but who in the opinion of the treating surgeon can have resectable disease can be included provided they fulfill all other eligibility criteria and provided they have one of the following presentations: 1. Invasion of orbital apex without involvement of the cavernous sinus 2. Dura invasion depending on extent of involvement and if total resection is deemed feasible. 3. Brain/middle cranial fossa invasion depending on extent of involvement if total resection is deemed feasible. 4. Nasopharynx invasion if very limited 5. Clivus invasion if very limited. (Surgeons are encouraged to consult with the protocol surgical chair for these particular cases). Stages T3 and T4a and selected T4b disease will be included regardless of nodal status (N0 or N1-3), provided that surgical therapy would require orbital or skull base resection. The surgical oncologist in each institution will determine the need for resection of the orbit OR base of skull at baseline for patients on both Arms A and B and following neoadjuvant chemotherapy for patients on Arm B using the score sheet provided at the end of the protocol. * Resection of skull base will be deemed necessary according to skull base bone erosion by computed tomography (CT) or marrow involvement by magnetic resonance imaging (MRI) is noted; for any disease abutting the skull base * Resection of orbital contents will be deemed necessary according to skull base society guidelines, based on involvement of periorbital fat documented by MRI imaging
- Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization
- Patients may not be receiving investigational agents at time of randomization, or at any time while on study and during the 4 weeks preceding randomization
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel and/or both platinum-based chemotherapy agents are ineligible; patient must be able to receive at least one of the two proposed chemotherapy regimens
- Patients with evidence of distant metastases or leptomeningeal disease (LMD) are ineligbile
- Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
- Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are ineligbile
- Patients with a history of a different malignancy are ineligible, unless the disease has not progressed for >= 2 years
- Absolute neutrophil count (ANC) > 1500/mm^3 (=< 2 weeks prior to randomization)
- Hemoglobin (Hgb) > 8.0 g/dL (=< 2 weeks prior to randomization)
- Platelet count > 100,000/mm^3 (=< 2 weeks prior to randomization)
- For patients receiving cisplatin, creatinine clearance must be > 60 ml/min (=< 2 weeks prior to randomization); creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockcroft-Gault formula
- Total bilirubin within 1.5 x the upper limit of normal (ULN) (must be obtained =< 2 weeks prior to randomization)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)
- Alkaline phosphatase must be within 1.5 x ULN allowing for eligibility (must be obtained < 2 weeks prior to randomization)
- Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
- Patient must not have current peripheral neuropathy > grade 2 at time of randomization
- Patient must not have any co-existing condition that would preclude full compliance with the study; no prior history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the chemotherapy and radiation being used; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy * All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achived menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient must not be expected conceive or father children by using an accepted and effective method(s) of contraception or by abstain from sexual intercourse for the duration of their participation in the study
- Patient must have measurable disease; MRI and/or PET/CT scans need to be performed within 2 weeks prior to randomization
United States
AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact
AZ
Tucson
Banner University Medical Center - Tucson
Contact: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu
University of Arizona Cancer Center-North Campus
Contact: Site Public Contact
Email: UACC-IIT@uacc.arizona.edu
University of Arizona Cancer Center-Orange Grove Campus
Contact: Site Public Contact
CA
La Jolla
UC San Diego Moores Cancer Center
Contact: Site Public Contact
Email: cancercto@ucsd.edu
Palo Alto
Stanford Cancer Institute Palo Alto
Contact: Site Public Contact
Email: ccto-office@stanford.edu
VA Palo Alto Health Care System
Contact: Site Public Contact
CT
New Haven
Smilow Cancer Center/Yale-New Haven Hospital
Contact: Site Public Contact
Email: canceranswers@yale.edu
Yale University
Contact: Site Public Contact
Email: canceranswers@yale.edu
FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact
Tampa
Moffitt Cancer Center
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
Moffitt Cancer Center - McKinley Campus
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
Moffitt Cancer Center-International Plaza
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org
GA
Atlanta
Emory Proton Therapy Center
Contact: Site Public Contact
Email: allyson.anderson@emory.edu
Emory University Hospital Midtown
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Emory University Hospital/Winship Cancer Institute
Contact: Site Public Contact
IA
Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org
Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
Contact: Site Public Contact
Mission Cancer and Blood - Des Moines
Contact: Site Public Contact
West Des Moines
Methodist West Hospital
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Meridian
Idaho Urologic Institute-Meridian
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
IL
Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
Centralia
Saint Mary's Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Chicago
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu
Rush University Medical Center
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Email: clinical_trials@rush.edu
University of Illinois
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Evanston
NorthShore University HealthSystem-Evanston Hospital
Contact: Site Public Contact
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Contact: Site Public Contact
Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
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Urbana
Carle Cancer Center
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Email: Research@carle.com
The Carle Foundation Hospital
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Email: Research@carle.com
KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org
Kansas City
University of Kansas Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Lawrence
Lawrence Memorial Hospital
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG
Olathe
Olathe Health Cancer Center
Contact: Site Public Contact
Email: Jeni.wakefield@olathehealth.org
Overland Park
University of Kansas Cancer Center-Overland Park
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Pittsburg
Ascension Via Christi - Pittsburg
Contact: Site Public Contact
Email: jennifer.jameson@ascension.org
Salina
Salina Regional Health Center
Contact: Site Public Contact
Email: mleepers@srhc.com
Topeka
University of Kansas Health System Saint Francis Campus
Contact: Site Public Contact
Westwood
University of Kansas Hospital-Westwood Cancer Center
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
KY
Louisville
The James Graham Brown Cancer Center at University of Louisville
Contact: Site Public Contact
UofL Health Medical Center Northeast
Contact: Site Public Contact
Email: ctoinfo@louisville.edu
MA
Boston
Massachusetts General Hospital Cancer Center
Contact: Site Public Contact
Tufts Medical Center
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org
MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact
Brownstown
Henry Ford Cancer Institute-Downriver
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Dearborn
Henry Ford Medical Center-Fairlane
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org
Farmington Hills
Weisberg Cancer Treatment Center
Contact: Site Public Contact
Email: ctoadmin@karmanos.org
Jackson
Allegiance Health
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Email: CTOResearch@hfhs.org
Novi
Henry Ford Medical Center-Columbus
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Contact: Site Public Contact
Email: tpearce1@hfhs.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Contact: Site Public Contact
Email: CTOResearch@hfhs.org
MN
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact
Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org
Creve Coeur
Siteman Cancer Center at West County Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net
Kansas City
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact
Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net
Siteman Cancer Center at Christian Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Washington University School of Medicine
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Contact: Site Public Contact
Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
Mercy Hospital Springfield
Contact: Site Public Contact
MT
Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org
Bozeman
Bozeman Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Kalispell
Logan Health Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Missoula
Community Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu
ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu
NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact
Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact
Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact
NY
Bay Shore
Northwell Health Imbert Cancer Center
Contact: Site Public Contact
Bronx
Montefiore Medical Center - Moses Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org
Montefiore Medical Center-Weiler Hospital
Contact: Site Public Contact
Email: eskwak@montefiore.org
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org
Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact
New Hyde Park
Long Island Jewish Medical Center
Contact: Site Public Contact
New York
Lenox Hill Hospital
Contact: Site Public Contact
Manhattan Eye Ear and Throat Hospital
Contact: Site Public Contact
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Mount Sinai Chelsea
Contact: Site Public Contact
Email: CCTO@mssm.edu
Mount Sinai Hospital
Contact: Site Public Contact
Email: CCTO@mssm.edu
Mount Sinai Union Square
Contact: Site Public Contact
Email: CCTO@mssm.edu
Rochester
University of Rochester
Contact: Site Public Contact
OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Contact: Site Public Contact
Email: cancer@uchealth.com
West Chester
University of Cincinnati Cancer Center-West Chester
Contact: Site Public Contact
Email: cancer@uchealth.com
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
PA
Beaver
UPMC-Heritage Valley Health System Beaver
Contact: Site Public Contact
Email: haneydl@upmc.edu
Carlisle
Carlisle Regional Cancer Center
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Erie
UPMC Hillman Cancer Center Erie
Contact: Site Public Contact
Email: haneydl@upmc.edu
Farrell
UPMC Cancer Center at UPMC Horizon
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Contact: Site Public Contact
Harrisburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Contact: Site Public Contact
Email: klitchfield@PINNACLEHEALTH.org
Mechanicsburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Contact: Site Public Contact
Email: haneydl@upmc.edu
Moon Township
UPMC Hillman Cancer Center in Coraopolis
Contact: Site Public Contact
Email: haneydl@upmc.edu
New Castle
UPMC Jameson
Contact: Site Public Contact
Philadelphia
Thomas Jefferson University Hospital
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu
Pittsburgh
UPMC-Passavant Hospital
Contact: Site Public Contact
UPMC-Presbyterian Hospital
Contact: Site Public Contact
UPMC-Shadyside Hospital
Contact: Site Public Contact
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact
Washington
UPMC Washington Hospital Radiation Oncology
Contact: Site Public Contact
Email: cancer@washingtonhospital.org
York
UPMC Memorial
Contact: Site Public Contact
SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org
TX
Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu
Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu
VA
Fairfax
Inova Schar Cancer Institute
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org
Falls Church
Inova Fairfax Hospital
Contact: Site Public Contact
Email: Stephanie.VanBebber@inova.org
VT
Saint Johnsbury
Dartmouth Cancer Center - North
Contact: Site Public Contact
Email: cancer.research.nurse@hitchcock.org
WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact
Minocqua
Marshfield Medical Center - Minocqua
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Marshfield Clinic-Wausau Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Weston
Diagnostic and Treatment Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
WY
Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
PRIMARY OBJECTIVES: I. Evaluate the structure preservation rate for patients with locally advanced resectable nasal and paranasal sinus squamous cell carcinoma (NPNSCC) with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care. II. Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care. SECONDARY OBJECTIVES: I. Evaluate progression-free survival (PFS) for this patient population. II. Examine the rate of structure preservation for the orbit (freedom from orbital exenteration). III. Evaluate site reported p16 data and correlate with outcome. IV. Determine the accuracy of baseline/post-chemotherapy magnetic resonance imaging (MRI) and/or fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG PET/CT)-based prediction of orbit and skull base preservation. V. Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival. EXPLORATORY TOBACCO USE OBJECTIVES: I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose modifications). II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo standard of care surgery. Beginning 4-6 weeks after surgery, patients undergo image guided intensity modulated radiation therapy (IMRT) once daily (QD) for 5 fractions per week for 30 fractions. Patients with positive margins/positive extracapsular spread (ECS) in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin intravenously (IV) over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Patients who are ineligible to receive cisplatin receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery no later than 6 weeks following the last dose of chemotherapy. Beginning 4-6 weeks after surgery, patients undergo image guided IMRT QD for 5 fractions per week for 30 fractions. Patients with positive margins/positive ECS in lymph nodes undergo image guided IMRT QD for 5 fractions per week for 30 fractions and cisplatin IV over 1-2 hours or carboplatin IV over 30 minutes (for patients who are ineligible to receive cisplatin) weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months if < 2 years from study entry and then every 6 months if 2-5 years from study entry.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.